MELBOURNE, Australia and PORTO ALEGRE, Brazil, March 18, 2025 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ‘ANVISA’) has approved Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) the Company’s lead prostate cancer imaging agent. Illuccix® is the first and only PSMA-PET[1] prostate cancer imaging agent to receive full regulatory approval in Brazil.

Illuccix®, after radiolabeling with 68Ga, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

• With suspected metastasis who are candidates for definitive initial therapy treatment, and
• With suspected recurrence based on an elevated specific antigen (PSA) level in the serum.

The marketing authorization is granted to Telix’s partner R2PHARMA, Brazil’s leading cold kit manufacturer, nuclear pharmacy and cyclotron network, and a subsidiary of GSH Corp Participações S.A. (Grupo GSH). Telix has provided Grupo GSH with an exclusive license to manufacture, distribute and market Illuccix® in Brazil[2].

PSMA-PET is a diagnostic technology demonstrated to detect advanced prostate cancer. ANVISA becomes the latest regulatory body worldwide to approve Illuccix®[3], which is already commercially available in Australia, Canada, New Zealand and the United States, and has recently been approved in the United Kingdom and in multiple countries within the European Economic Area (EEA).

Dr. Sérgio Altino de Almeida, nuclear medicine specialist, at Rede D’Or, the largest integrated healthcare network in Brazil said, “The ANVISA approval of Illuccix provides access to advanced prostate cancer imaging for men across Brazil, a large and rapidly growing market for gallium-68 based radiopharmaceuticals. The ‘cold kit’ format with generator-produced gallium will facilitate broad equity of access for men living with prostate cancer, regardless of whether they are based in regional, rural or metropolitan areas.”

JV to manufacture and distribute radiopharmaceuticals for clinical and commercial use in Brazil

Telix also announces a joint venture (JV) with R2PHARMA to commercialize and distribute Telix’s therapeutic and diagnostic radiopharmaceutical products in Brazil, building on the existing partnership established in 2019. The JV further strengthens this relationship with a commitment to jointly bring to market innovative and first-in-class therapeutic radiopharmaceuticals and imaging agents in Brazil.

The market for radiopharmaceuticals in Brazil is experiencing significant growth driven by the increasing prevalence of chronic diseases such as cancer, advancements in imaging technologies, and a growing senior population. Over the next decade, the Brazilian radiopharmaceuticals market is projected to reach US$330 million[4], with this growth supported by rising investments in the healthcare industry, public health awareness, and the introduction of new and advanced radiopharmaceuticals.

Under the agreement, Telix and R2PHARMA will establish a JV company in Brazil (Telix Innovations Brazil, Ltda.). Telix Innovations Brazil will hold the exclusive licence to commercialize and distribute Illuccix® as well as future product candidates from Telix’s industry-leading theranostic pipeline. Telix Innovations Brazil will leverage the local knowledge and expertise of R2PHARMA to obtain the necessary licenses and governmental authorizations in Brazil[5].

Raphaël Ortiz, CEO Telix International, added, “Telix is pleased to bring Illuccix to Brazil and Latin America, with this new imaging modality now recognized in leading clinical practice guidelines and already being adopted in other parts of the world. We would like to acknowledge our partner R2PHARMA for their commitment to gallium-based PSMA-PET and the hope this brings for men living with prostate cancer in Brazil. The JV takes our collaboration to the next stage with the aim to address unmet need for therapeutic and diagnostic radiopharmaceuticals across a range of disease areas.”

R2PHARMA Nuclear Medicine & Innovation Vice-President, Rafael Madke, continued, “We are delighted to have been granted this marketing authorization for Illuccix in Brazil. The combination of Telix’s innovative theranostic pipeline and R2PHARMA’s manufacturing and distribution capabilities will support widespread access for patients and physicians to Illuccix and future additional products that until now have not been available in Latin America.”

For more information visit: http://r2pharma.com.

Malaysian Prime Minister Datuk Seri Anwar Ibrahim. (Photo: Bernama)

Hanoi – Malaysian Prime Minister Anwar Ibrahim has warned that trade wars, tariffs, and sanctions are no longer just economic tools but have become weapons in the struggle for dominance, eroding trust and undermining the foundations of international cooperation.

In an article titled “The Global South Path’s to Economic Resilience”, published on Project Syndicate, Anwar noted that nations once seen as partners or market competitors now view each other merely as players in a global power struggle.

He wrote that with a new world order taking shape, countries must also recognise the growing challenges faced by nations across the Global South. Many mechanisms that once fueled their development are weakening, while development aid is being closely scrutinised by some of the world’s most powerful countries.

He warned that economic interdependence, once the backbone of global prosperity, has now become a source of tension. If this trend continues, connectivity itself can become a vulnerability, even for countries that have long thrived under globalisation.

As a trade-dependent nation, Malaysia acknowledges that global instability and protectionism make adaptability more crucial than ever, Anwar said.

However, he reaffirmed Malaysia’s commitment to sustainable, inclusive, and equitable growth, as well as its ambition to strengthen its position as a key hub for trade, investment, and technological innovation.

For these reasons, Malaysia has made the strategic decision to seek membership in BRICS, a bloc of major emerging economies, he added, emphasising that joining BRICS aligns with Malaysia’s goal of bridging the development gap between the Global North and South.

At SOWATCO port in Thu Duc city. (Photo: VNA)

Hanoi – Vietnam has set an ambitious export target of 454 billion USD for 2025, a 12 per cent year-on-year increase, despite recent signs of deceleration in exports due to global economic pressures.

Many experts believe that achieving this goal will require decisive actions from regulatory bodies and extraordinary efforts from businesses to overcome obstacles.

According to data from the Ministries of Finance and Industry and Trade, Vietnam exported 65.2 billion USD worth of products in January-February, a 9.9 per cent increase compared to the same period last year. Meanwhile, imports totaled 62.9 billion USD, rising 16 per cent, resulting in a trade surplus of 235 million USD.

Nguyen Anh Son, Director General of the Ministry of Industry and Trade (MoIT)’s Agency of Foreign Trade, identified key challenges to Vietnam’s exports, including its dependence on major markets like the US, the EU, and China. This reliance increases risks for businesses and makes the country vulnerable to global economic and political fluctuations.

Additionally, Vietnamese exports still fall short of international standards, making them less competitive as consumers increasingly demand quality and sustainability. Son also pointed out infrastructure constraints, particularly the discordant investment in seaports and transport systems, which result in high shipping costs and extended delivery times.

According to Son, insufficient market intelligence has left many companies struggling with production planning. Moreover, trade tensions between Vietnam’s largest trading partners could present both opportunities and challenges for exporters.

Do Ngoc Hung, head of the Vietnam Trade Office in the US, stated that these trade tensions could benefit Vietnam if the country manages to capture market share, but cautioned that businesses must navigate carefully. Enterprises must fully cooperate with US authorities during trade investigations and remain cautious with raw materials from countries subject to US tariffs to avoid allegations of origin fraud, Hung said.

Meanwhile, Vietnamese trade counselor in China Nong Duc Lai noted that the US-China trade tensions could shift investment flows to Vietnam, creating greater opportunities for Vietnamese businesses to integrate into global production chains.

To mitigate market impacts, Lai recommended that Vietnamese businesses closely monitor developments and policies from major trading partners, make timely forecasts and responses, and develop contingency plans for scenarios such as increased tariffs or supply chain disruptions. He also suggested diversifying export markets and enhancing product competitiveness and quality to expand market reach.

The MoIT has issued a directive outlining several solutions to develop markets, promote exports, and manage imports this year. The ministry advised businesses to closely track market developments, while Vietnamese trade offices abroad will continue updating industry associations on policy changes so businesses can adjust production plans and seek new orders accordingly. Efforts will also focus on exploring new markets, such as the Middle East and Halal markets.

Experts emphasised the importance of capitalising on free trade agreements, accelerating negotiations for new and upgraded pacts, and ensuring the domestic implementation of international commitments. Additionally, training on rules of origin for enterprises, along with efforts to combat origin fraud, improve logistics services, and promote digitalisation to streamline business operations, should be prioritised.